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Predictors and Intervention for Noncompliance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00148174
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : June 1, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.

Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Condition or disease Intervention/treatment
Kidney Transplantation Behavioral: Intensive telephone followup

Detailed Description:
Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictors and Intervention for Noncompliance
Study Start Date : August 1998
Primary Completion Date : November 2014
Study Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Phone calling
Phone calling to encourage improved adherence
Behavioral: Intensive telephone followup
Telephone calling

Outcome Measures

Primary Outcome Measures :
  1. Graft loss [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. Acute rejection [ Time Frame: prospective ]
  2. Death [ Time Frame: prospective ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Kidney transplant
  • Discharged from hospital with functioning graft

Exclusion Criteria:

  • Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
  • Patients with active psychosis
  • Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
  • Patients taking the liquid form of azathioprine or mycophenolate mofetil
  • Patients who are younger than 14 yrs. old
  • Patients who do not speak English
  • Receiving extra-renal organ except for pancreas,either simultaneously or previously
  • Patients who live and will be followed outside of the United States, except Canada
  • Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
  • Patients who are not responsible for taking their own medications, e.g. living in a medical care facility
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148174

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00148174     History of Changes
Other Study ID Numbers: 9611M11943
2P01DK013083-40A1 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Medication adherence
Patient compliance
Kidney transplant
Organ rejection
Allograft loss
Drug monitoring